Valacyclovir 1000 mg Tablet Under Fasting Conditions

NCT01149499 | Completed Phase 1

• 1 other identifier: R04-1770
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax (maximum observed concentration of drug substance in plasma)

  Bioequivalence based on Cmax

  Blood samples collected over 16 hour period

• AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)

  Bioequivalence based on AUC0-t

  Blood samples collected over 16 hour period

• AUC0-inf (area under the concentration-time curve from time zero to infinity)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 16 hour period

Study Arms (2)

Valacyclovir

EXPERIMENTAL

Test 1000 mg Valacyclovir Tablet

Drug: Valacyclovir

Valtrex

ACTIVE COMPARATOR

Reference Listed 1000 mg Valtrex Tablet

Drug: Valacyclovir

Interventions

Valacyclovir DRUG

1000 mg Tablet

Valacyclovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, non-smokers, 18 years of age and older.
• Capable of consent
• BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive testing for hepatitis B, hepatitis C or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol or drug abuse within one year prior to the screening visit
• Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40% alcohol\]) or positive urine drug screen at screening.
• Use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
• History of allergic reactions to heparin, valacyclovir, acyclovir, or other related drugs.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medication.
• Use of an investigational drug or participation in an investigation study within 30 days prior to the administration of the study medication.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

East Grand Forks, Minnesota, 56721, United States

Location

MeSH Terms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James D Carlson, Pharm. D

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: January 1, 2005
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: June 23, 2010

Record last verified: 2010-06

Locations

US (1)